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Focus Diagnostics, Inc.
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PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G is an FDA 510(k)-cleared medical device (K071511) manufactured by Focus Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2007. Regulation: 8.